search
Back to results

Prospective Evaluation of Decision and Compliance With Antimalarials in Patients With Systemic Lupus (ESSTIM)

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
therapeutic education
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Systemic Lupus Erythematosus focused on measuring systemic lupus erythematosus, antimalarials, therapeutic education, Coping questionnaire, MASRI questionnaire, morisky medication adherence scale, lupus Quality Of Life, internal medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with a systemic lupus with ACR criteria (at least 4 criterias)
  • patients with antimalarials for at least 3 months with a minimum dose of 200 mg/day.

Exclusion Criteria:

  • patients who refuse to sign the informed consent
  • patients who are under guardianship

Sites / Locations

  • CH Hôpital Duchenne
  • CH Douai
  • CH Dunkerque
  • CH du Dr Schaffner
  • CHRU, Hôpital Huriez
  • Victor Provo Hospital
  • Valenciennes hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with Systemic Lupus

Arm Description

Outcomes

Primary Outcome Measures

measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment.

Secondary Outcome Measures

hydroxychloroquinémie
Monitoring of blood levels of hydroxychloroquinémie
number of non- adherent patients
Identification of the number of non- adherent patients are being enrolled in Education Protocol Patient and number of sessions followed ;
quality of life scale Coping
scale Coping ( WCC-R Par COUSSON et al. (1996) ) scale MASRI, scale MMAS-8-item

Full Information

First Posted
February 10, 2015
Last Updated
October 12, 2018
Sponsor
University Hospital, Lille
Collaborators
Région Nord-Pas de Calais, France
search

1. Study Identification

Unique Protocol Identification Number
NCT02364908
Brief Title
Prospective Evaluation of Decision and Compliance With Antimalarials in Patients With Systemic Lupus
Acronym
ESSTIM
Official Title
Prospective Evaluation of Adherence to Antimalarials in Patients With Systemic Lupus and Role of Therapeutic Education
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Région Nord-Pas de Calais, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a biomedical, open label, therapeutic strategy, interventional, non-randomized, multicenter study to evaluate the non compliance to antimalarials in patients with systemic lupus in the Nord Pas-de-Calais region (FRANCE). It is conducted in two visits. These visits consist in obtaining blood sample, performing a clinical examination and filling in a questionnaire (Quality Of Life, Coping...). The goal for the noncompliants patients is to guide them towards the therapeutic education with professionals (nurses and physicians).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
systemic lupus erythematosus, antimalarials, therapeutic education, Coping questionnaire, MASRI questionnaire, morisky medication adherence scale, lupus Quality Of Life, internal medicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with Systemic Lupus
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
therapeutic education
Intervention Description
This is the group sessions aimed to convey additional information to patients about their disease. The main objective is to learn how to better anticipate any medical problems and better manage daily life with the disease.
Primary Outcome Measure Information:
Title
measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment.
Time Frame
baseline, at 12 months
Secondary Outcome Measure Information:
Title
hydroxychloroquinémie
Description
Monitoring of blood levels of hydroxychloroquinémie
Time Frame
between 6 months at 12 months
Title
number of non- adherent patients
Description
Identification of the number of non- adherent patients are being enrolled in Education Protocol Patient and number of sessions followed ;
Time Frame
at 12 months
Title
quality of life scale Coping
Description
scale Coping ( WCC-R Par COUSSON et al. (1996) ) scale MASRI, scale MMAS-8-item
Time Frame
baseline, at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with a systemic lupus with ACR criteria (at least 4 criterias) patients with antimalarials for at least 3 months with a minimum dose of 200 mg/day. Exclusion Criteria: patients who refuse to sign the informed consent patients who are under guardianship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Hachulla, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Study Chair
Facility Information:
Facility Name
CH Hôpital Duchenne
City
Boulogne sur Mer
ZIP/Postal Code
62321
Country
France
Facility Name
CH Douai
City
Douai
ZIP/Postal Code
59507
Country
France
Facility Name
CH Dunkerque
City
Dunkerque
ZIP/Postal Code
59385
Country
France
Facility Name
CH du Dr Schaffner
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Name
CHRU, Hôpital Huriez
City
Lille
Country
France
Facility Name
Victor Provo Hospital
City
Roubaix
ZIP/Postal Code
59056
Country
France
Facility Name
Valenciennes hospital
City
Valenciennes
ZIP/Postal Code
59322
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prospective Evaluation of Decision and Compliance With Antimalarials in Patients With Systemic Lupus

We'll reach out to this number within 24 hrs